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Health Sciences Authority
HSA Revised Guidance on Medical Device Product Registration: Specific Aspects | HSA
Medical Devices
February 19, 2024
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework. Table of content ...
Top News
HSA Draft Guidance on Clinical Evaluation: Data Sources | RegDesk
Medical Devices
November 29, 2023
HSA Draft Guidance on Clinical Evaluation: Definitions | RegDesk
Medical Devices
November 22, 2023
Guardant Health introduces CRC screening test in South Korea
Medical Devices
November 13, 2023
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HSA Guidance on Site Master File Preparation: Overview
Medical Devices
March 30, 2023
The document describes in detail the aspects to be taken into account when preparing a site master file....
HSA Guidance on “Dear Healthcare Professional” Letters: Overview
Medical Devices
March 14, 2023
The article provides an overview of the regulatory requirements related to the content of special communications to be...
HSA Guidance on Complaints Handling: Overview
Medical Devices
March 2, 2023
The document highlights the key points related to the regulatory requirements for handling complaints associated with medical devices...
HSA Guidance on Recalls: Overview
Medical Devices
February 28, 2023
The article provides an overview of the regulatory requirements for medical device recalls. ...
HSA Guidance on FSCA: Specific Aspects
Medical Devices
February 28, 2023
The new article highlights the aspects related to field safety corrective actions including, inter alia, the record-keeping requirements,...
HSA Guidance on Field Safety Corrective Actions: Risk Management Process
Medical Devices
February 23, 2023
The new article highlights the aspects related to the risk management process for the supply of medical devices. ...
HSA Guidance on FSCA: Specific Device Types
Medical Devices
February 20, 2023
The new article highlights the aspects related to the specific associated with certain types of medical devices, including...
HSA Guidance on FSCA: Content of Reports
Medical Devices
February 17, 2023
The new article highlights the aspects related to the content of reports to be submitted by the parties...
HSA Guidance on FSCA: Initiating the Actions
Medical Devices
February 17, 2023
The new article highlights the aspects related to the commencement of corrective actions and the appropriate notification requirements....
HSA Guidance on Reclassification: Medical Devices to be Introduced Into the Body
Medical Devices
January 16, 2023
The article provides an overview of the changes to the applicable classification rules with respect to a specific...
HSA Guidance on Adverse Events Reporting: IVDs and Timelines
Medical Devices
January 16, 2023
The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical...
HSA Guidance on the Reporting of Adverse Events: Overview
Medical Devices
December 8, 2022
The article provides an overview of the regulatory requirements in the sphere of adverse event reporting. ...
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Latest Intelligence
HSA Guidance on Medical Device Advertisements and Sales Promotion: Specific Rules and Corrective Measures
Medical Devices
December 6, 2022
HSA Guidance on Advertising and Promotion: General Principles
Medical Devices
November 29, 2022
HSA Guidance on Medical Device Advertisements and Sales Promotion: Overview
Medical Devices
November 16, 2022
HSA Guidance on Change of Registrant: Overview
Medical Devices
October 26, 2022
HSA Guidance on Change Notification: Change Type Flowcharts
Medical Devices
October 13, 2022
HSA Guidance on Change Notification: FSCA-related Changes and Exemptions
Medical Devices
October 4, 2022
HSA Guidance on Change Notification: Categories of Changes
Medical Devices
September 27, 2022
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